Achieve Life Sciences announces several milestones in its ORCA-OL trial

Achieve Life Sciences (ACHV) announced several milestones in its ORCA-OL long-term safety trial supporting the New Drug Application, NDA, review process of cytisinicline for smoking cessation. 120-Day Safety Update: The company has submitted the 120-day safety update to the U.S. Food and Drug Administration as part of the NDA review for cytisinicline. This update provides the most current and comprehensive long-term safety data available and includes data on 411 participants with at least six months of cumulative cytisinicline exposure and 214 participants with at least one year of cumulative cytisinicline exposure as of the agreed upon data cutoff on June 4, 2025. ORCA-OL Trial Completion: Achieve reported that the last participant in the ORCA-OL long-term safety trial completed treatment in October 2025, marking 334 participants who finished one full year of cytisinicline treatment. Data Safety Monitoring Committee: The company announced completion of the fourth and final scheduled safety review by the DSMC for the ORCA-OL trial. Adverse events were mostly mild in severity, and no serious adverse events were deemed to be treatment related.